Advanced Therapy Quality Assurance Assistant: Sponsorship Available

Guy's and St Thomas' NHS Foundation Trust

Job summary

The Advanced Therapy Good Manufacturing Practice (GMP) Unit is co-located with the Clinical Research Facility (CRF) at Guy’s Hospital on the 15th floor of the tower. The GMP Unit is purpose built for the manufacture of Advanced Therapy Medicinal Products such as somatic cell therapies, gene therapies and tissue engineered products for early-phase clinical trials. It is used for both commercial and non-commercial clients as well as departments within GSTFT and KCL to manufacture products related to trials undertaken in the CRF and at trial sites across the UK.

The post holder will be personally responsible for supporting all QA activities. The unit itself holds a GMP licence for manufacturing of T-Reg cell therapies and CAR T-Cell gene therapies as well as new manufacturing processes. The post holder will also be responsible for organising systems and procedures to ensure compliance with current UK & EU legislation and Trust requirements. This will also include responsibility for following policies and standard operating procedures for manufacturing and quality assurance of the GMP Unit. The post holder will be responsible for the day to day QA queries from core staff and collaborators using the unit equipment and systems and ensuring that GMP compliance is maintained.

Main duties of the job

  • Operate within the PQS: Reviewing Planned Deviations, by assessing impact/risk on the manufacturing or testing process prior to its implementation. Report deviations through Quality deviations to line managers. You will undertake Preventive Actions and Change Controls to rectify exceptions and implement audit and inspection findings.
  • Assist in the management and monitoring of QA and QC activities, ensuring that agreed quality standards of service are maintained. Enable preparation of quality data to be used in the certification of ATMPs.
  • Undertake strategic judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the PQS, such as: how to proceed during technical failures; PPM; Quality Control assessments; technical decisions; suitability of material for manufacture; analysis of anomalous results.
  • Contribute to quality meetings internally and with collaborators, tracking the progress of open deviations and reporting on KPIs
  • Understand how an electronic PQS operates and assist in the design and qualification in a new system. Have the ability to keep PQS logs current and escalate upcoming overdue items to appropriate personnel including the Heads of unit

Person Specification

Qualifications

Essential

  • BSc in Immunology, Haematology or equivalent experience

Desirable

  • PhD and/or MSc in Immunology, Haematology or equivalent

Experience

Essential

  • 2 years experience working in Quality Assurance
  • Expert knowledge and hands on experience of Good Manufacturing Practice (GMP) or equivalent.
  • Experience with process qualification, and equipment validation for GMP

Desirable

  • Specialist knowledge relating to the manufacture of somatic cell and gene therapy products within GMP
  • Experience in cellular immunology techniques and analyses: proliferation, characterisation, and safety tests
  • Specialist knowledge of: environmental monitoring, GMP unit cleaning, maintenance and qualification of specialist equipment

Skills

Essential

  • Ability to work independently
  • Ability to work collaboratively and as part of a team
  • Ability to communicate complex ideas verbally and in writing.

Desirable

  • Specialist knowledge of deviation management within a pharmaceutical quality system
  • Experience in training staff and students

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Closing Date: 1 November 2026

To apply for this job please visit apps.trac.jobs.